Chewable soft capsules

ABSTRACT

A matrix formulation for a soft chewable capsule is provided which includes a gel-forming composition, a plasticizer, a polymer modifier, and water. The polymer modifier may be a carboxylic acid or other organic compound that alters the physical and/or chemical properties of the capsule formulation. A chewable soft capsule is also provided, having enhanced organo-leptic and processing properties. An active material may be delivered to a user using this dosage form. A method of forming the chewable soft capsule is also provided.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/327,293, filed Dec. 15, 2011, which is a divisional of U.S.patent application Ser. No. 10/512,318, filed Oct. 22, 2004, now U.S.Pat. No. 8,097,279, which is a national stage application under 35U.S.C. §371 of International Application No. PCT/US03/12983, filed Apr.24, 2003, which claims benefit of priority under 35 U.S.C. §119 to U.S.Provisional Patent Application No. 60/375,479, filed on Apr. 25, 2002,the contents of each which are hereby incorporated by reference in theirentirety. This application is related to U.S. patent application Ser.No. 13/270,005, filed Oct. 10, 2011, now U.S. Pat. No. 8,241,665 andU.S. patent application Ser. No. 13/491,670, now U.S. Pat. No.8,414,916, the contents of each which are hereby incorporated byreference in their entirety.

TECHNICAL FIELD

The present invention relates generally to a chewable matrixcomposition. The invention also relates to chewable soft capsules and toa process for their preparation, and in particular to chewable softcapsules having a controllable chewable consistency.

BACKGROUND

Chewable dosage forms are manufactured as solids, such as chewabletablets, or elastic semi-solids such as chewing gums, molded gels, orchewable soft capsules. While elastic semi-solid forms provide bettermouth feel and customer acceptance, chewable soft capsules have afurther benefit of being totally ingestible and can deliver accurateamounts of active ingredients.

Soft capsules formed of a sheath encapsulating a fill or a matrix areone type of dosage form generally used for administering perorally amedicament, vitamin, nutritional supplement, or other material. Certaintypes of these soft capsules are designed to be chewed by the user.Chewable soft capsules, or chewable soft gels, are traditionallydesigned so that the user chews upon the capsule to release the fillinto the mouth, instead of swallowing the capsule with the fill stillencapsulated within the sheath. Chewable capsules are particularlysuitable for administering analgesics, vitamins, minerals and coldremedies. After the fill has been released, the user chews the fracturedsheath until it is partially or completely dispersed. Alternatively, thesheath may include a chewing gum base material that is not made forswallowing.

Although chewable soft capsules provide an effective dosage system, useracceptance has been limited by the capsules' organo-leptic properties,which are sometimes criticized as being leathery or rubbery, as well asthe difficulty that some users experience in consuming the fracturedsheaths after the fills have been released. Current soft capsules sharethe disadvantage of having a distinguishable difference between thesheath and fill in terms of texture and mouth-feel. In addition, theytend to harden over time. The objective of this invention is to addressthese issues and limitations.

SUMMARY

The present invention is directed generally to a soft capsule useful asa dosage delivery system. The soft capsule, when used as an oral dosageform, exhibits a consistency, texture and other organo-leptic propertiesfound desirable in a chewable capsule. The capsule, which is suitablefor chewing, generally includes a gel-forming polymer, a plasticizer, apolymer modifier, and, water. The capsule also includes an activeingredient that is to be delivered to the user, and optionally containsflavoring agent, sweetener, and/or a taste-masking agent.

In one embodiment, the soft capsule generally includes a matrixencapsulated in a sheath. The matrix is formed of a gel-forming polymer,a first plasticizer, water and a polymer modifier. The sheath is formedof a second gel-forming polymer and a second plasticizer. The activeingredient may be contained within the matrix. One or both of the firstand second gel-forming polymers may be a gelatin that exhibits a Bloomin a predetermined range.

In one particular embodiment, the matrix includes a gelatin exhibiting aBloom in the range of about 0 to about 250. The sheath includes agelatin that exhibits a Bloom in the range of about 80 to about 250.

In another embodiment, the soft capsule has a matrix formed of a gelatinthat exhibits a Bloom in the range of about 0 to about 80 and a sheaththat exhibits a Bloom in the range of about 100 to about 150.

In yet another embodiment, the matrix includes a gelatin exhibiting aBloom in the range from about 20 to about 250.

In yet another embodiment, the matrix includes a gelatin exhibiting aBloom in the range from about 40 to about 80.

The polymer modifier used to form the matrix of the soft capsule of thepresent invention generally includes a carboxylic acid. In oneembodiment, the polymer modifier used to form the matrix of the softcapsule is selected from lactic acid, fumaric acid, tartaric acid,citric acid, glycolic acid, and combinations thereof.

The plasticizer used to form the matrix and/or sheath of the softcapsule may include a polyol. In another particular embodiment, the softcapsule is formed using a plasticizer selected from glycerol, sorbitol,maltitol, xylitol, and combinations thereof.

A method of making a soft capsule is also encompassed by the presentinvention. The method generally includes the step of combining agel-forming polymer with a polymer modifier, incubating the combinedgel-forming polymer and polymer modifier to form a matrix; and,encapsulating the matrix to form a chewable soft capsule.

In one embodiment, the method of forming a chewable soft capsule foradministering an oral dosage of an active ingredient includes the stepsof: mixing a gelatin, a plasticizer, a polymer modifier, and watertogether to form a matrix, incubating the matrix, cooling the matrix,and encapsulating the matrix in a sheath. In this embodiment, thegelatin exhibits a Bloom in the range of about 0 to about 250 and theplasticizer includes a polyol. Also, the polymer modifier includes acarboxylic acid and the sheath includes a plasticizer and a gelatin thatexhibits a Bloom in the range of about 80 to about 250.

These and other embodiments and advantages are contemplated by thepresent invention, which is set forth in detail below.

DETAILED DESCRIPTION

This invention provides chewable soft gel compositions that minimize orreduce the traditional user's complaints regarding a perceived majordifference in texture between the matrix and the capsule shell or sheaththat is a result of the current technology. Therefore, this inventiondescribes chewable softgel compositions with homogeneous, controllablemouth-feel for the whole capsule.

The soft gel is made from a hydrophilic matrix comprising a gel-formingpolymer and its oligomers or hydrolysates, in presence of a polymermodifier that can control the texture, viscosity, and melting point ofthe matrix. In addition, the sheath comprises a polymer modifier, alongwith the gel-forming polymer composition, and plasticizer. Such acombination has the benefit of providing a stable composition where masstransfer between the shell and the matrix is reduced due to thestructural similarity between the matrix and the shell.

A soft capsule exhibiting organo-leptic properties that are appropriatefor use as a chewable dosage form for delivering therapeutic,diagnostic, and/or dietary agents is set forth herein. The organo-lepticproperties of the soft capsule, such as, for example, texture, andchewiness, are enhanced by the polymer modifier included in the capsuleformulation. In addition, the polymer modifier enhances the physicaland/or chemical properties of the gel forming polymers that are used toform the capsule matrix and/or sheath, thereby facilitating theprocessing of the soft capsule. The soft capsules generally include ahydrophilic, water soluble matrix that includes one or more activeingredients and is encapsulated in hydrophilic, watersoluble sheath. Thematrix and the sheath are generally formed of similar materials,although variations in their compositions are contemplated by thepresent invention.

As used herein, the terms “gel-forming polymer” and “gel-formingcomposition” refer to any natural or synthetic polymeric material orpartial hydrolysate of a polymer that can form a gel when appropriatelydissolved or dispersed in water or aqueous media. Examples ofgel-forming compositions include proteins such as different types ofgelatins from different sources. Specific examples are: acid and limebone bovine gelatins; pig bone gelatin; skin pig gelatin; skin bovinegelatin; and fish gelatin. Other examples of gel-forming compositionsare of polysaccharide nature. Specific examples are: sodium and calciumalginate; natural and modified starch and starch hydrolysates; pectinsand amylopectins; and cellulose derivatives, such ashydroxypropyl-methyl cellulose, and carboxymethyl cellulose, and saltsthereof. A gel-forming composition can be a hydrophilic polymer, aloneor in combination with its building units, its oligomers, orhydrolysate. As used in the present description, the term “activeingredient” is intended to include therapeutic, diagnostic ornutritional agents, such as medicaments, vitamins, minerals, fruitextracts, herbals and other encapsulatable materials that are intendedfor local effect in the mouth or the gastro-intestinal tract, or forsystemic effect, or combinations thereof understood by those skilled inthe art to support the desired effect. Examples of active ingredientsuseful in this application are: anti-asthmatic drugs such as salbutamol,theophylline; anti-epileptic drugs such as phenytoin; analgesics such asparacetamol, naproxen, ibuprofen, aspirin, meloxicam, and celecoxib;nonsteroidal anti-inflammatory drugs (NSAIDs); beta-lactam antibioticssuch as amoxycillin; macrolide antibiotics such as azythromycin, andclarythromycin; mineral supplements, such as iron, potassium, calcium,magnesium supplements and salts thereof; and vitamins, such as vitaminsC, B complex, A, E, K, and D; and other food supplements.

As used herein, “polymer modifier” refers to a pharmaceuticallyacceptable compound that has the ability, under the appropriate processconditions, to alter one or more physical and/or chemical properties ofone or more of the gel-forming polymers disclosed herein or generallyknown for use in soft capsule formulations, so as to enhance theperformance characteristics of the capsule formulation during processingand/or the performance characteristics and/or physical properties of thefinished capsule product.

The polymer modifier of the present invention is included in the softcapsule of the present invention in order to alter one or more physicaland/or chemical characteristics of the gel-forming polymers that arecontained in the capsule formulations. As an example, the polymermodifier may reduce the melting point of the gel-forming polymer in thematrix formulation. With the melting point reduced, less heat isrequired to place the gel-forming polymer in a liquid state, therebyreducing the energy cost and time required to process the formulationand allowing the incorporation of heat-sensitive drugs or agents.

In addition to a possible reduction in the melting point of thegel-forming polymer, the polymer modifier may reduce the viscosity ofone or more of the gel-forming compositions found in the capsuleformulation, thereby providing a formulation that may flow more easilyduring processing (a “flowable” composition). Again, capsulemanufacturing may be facilitated by such an alteration. Gel modifier canalso prevent gel hardening upon gel storage and improve thedisintegration and dissolution of the chewable products in the mouth.

A third illustrative example of the effect that the polymer modifier mayhave is a reduction of the molecular weight of one or more gel-formingpolymers of the capsule formulation. Such a reduction also tends toaffect other physical properties of the gel-forming polymers, bothduring capsule production and in the finished capsule product. Thepolymer modifier of the present invention also may enhance the textureor chewiness of the finished soft capsule. The capsule texture may tendto be less “leathery” than it would be in the absence of the polymermodifier, thereby providing a more acceptable mouth feel for the capsuleuser.

Although these particular examples are set forth herein describing thepossible impact the polymer modifier has upon the capsule formulationand the finished capsule product, these examples are provided for thepurpose of illustration and not to limit the scope of the presentinvention. These specific possible effects need not occur in order for acapsule formulation to fall within the scope of the present invention.Indeed, these and/or other effects may be realized by the inclusion of apolymer modifier into a capsule formulation, thereby providing a softcapsule that is acceptable for chewing.

Soft gel capsules generally are produced by a rotary die process as setforth by J. P. Stanley in “The Theory and Practice of IndustrialPharmacy,” L. Lachman, (editor), Lea and Febiger (publisher),Philadelphia (1976), which is incorporated by reference as if fully setforth herein. In the process of the invention, a molten mass of agel-forming polymer, such as, for example, a gelatin formulation, is fedfrom a reservoir onto drums to form two spaced sheets or ribbons ofgelatin in a semi-molten state. These ribbons are fed around rollers andbrought together at a convergent angle into the nip of a pair of rollerdies that include opposed die cavities. A matrix containing an activeingredient to be encapsulated is fed into the wedge-shaped joinder ofthe ribbons.

The gelatin ribbons are continuously conveyed between the dies, withportions of the matrix being trapped between the sheets inside the diecavities. The sheets are then pressed together, and severed around eachdie so that opposed edges of the sheets flow together to form acontinuous gelatin sheath around the entrapped medicament. The part ofthe gelatin sheet that is severed from the segments forming the capsulesmay then be collected for recycling. The very soft capsules are thendried to increase the integrity of the sheath, and packaged for laterdistribution and consumption.

The chewable soft capsules of the present invention are generally formedby combining the gel-forming composition, polymer modifier, plasticizer,and water with or without mixing, and while maintaining the heat of themixture in a range between about 40 and about 75 degrees Celsius. Thismatrix mixture is then allowed to incubate for about 4 to about 72hours, while its temperature is maintained in the range of about 40 toabout 75 degrees Celsius. The matrix mixture is then cooled to atemperature in the range of about 30 to about 40 degrees Celsius.

The matrix mixture is then encapsulated. The capsules are thenair-cooled to a temperature in the range of about 5 to about 25 degreesCelsius. The capsules are also dried to a final water content of a rangeof about 5 to about 20 percent by weight. Final water content can alsobe from about 5 to about 10 percent. Prior to drying, the matrix cancomprise water from about 20% to about 50% by weight. Prior to drying,water content can also be about 25% to about 35% by weight. Activeingredients can be added from the start of preparing the gel mass, ifthey are chemically and physically stable. Unstable actives can beadded, preferably as a last step before encapsulation to minimize anypossibility for degradation. The performance properties of a gel-formingcomposition are affected in part by its cohesive strength, which, in thecase of at least gelatin, is expressed as “Bloom.” This Bloom value isdetermined by measuring the weight in grams required to move a plunger0.5 inch in diameter, 4 mm into a 6.67% gelatin gel that has been heldfor 17 hours at 10° C.

Chewable soft gel capsules are designed to at least partially disperseor dissolve in the user's mouth, upon chewing, within a brief period oftime so that the chewable mass can be swallowed. Therefore, in additionto the above properties, the remains of the capsule should tend to besoluble after the active ingredient has been released. These remainsshould also have a good “mouth feel.” As used herein, “mouth feel”describes chewability. Chewing the capsule remains should be a pleasant,or at least not an unpleasant, sensation that results in a swallowablecomposition.

Surprisingly, it has been found that a chewable soft capsule havingthese desired characteristics can be produced from a capsule formulationincluding an appropriate amount of polymer modifier that alters one ormore characteristics of the gel-forming composition therein. Such acapsule formulation, examples of which are provided below, has beenfound to produce chewable soft capsules that exhibit a desirablemouth-feel and solubility.

In one embodiment, the matrix formulation, prior to drying, of thepresent invention includes the following ingredients in the specifiedpercentages:

TABLE 1 Matrix Formulations INGREDIENT % BY WEIGHT Gel-Formingcomposition 15-80 Polymer modifier 0.1-10  Plasticizer  5-40 Water  5-30Active Ingredient 0.01-70  Other Ingredients, e.g., flavors, sweeteners,0.01-15  and taste - masking known in the industry

The gel-forming polymer of the above embodiment may be a gelatin thatexhibits a Bloom in the range of about 0 to about 250. The plasticizermay be a polyol, such, for example, glycerol, sorbitol, maltitol,xylitol, or combinations thereof. The polymer modifier may be a mono,di, or poly carboxylic acid. More specifically, the polymer modifier maybe lactic acid, fumaric acid, tartaric acid, citric acid, glycolic acidor a combination of two or more of these acids.

In this embodiment, the capsule may also include a sheath formulation(before drying) including the following ingredients in the specificranges:

TABLE 2 Sheath Formulations INGREDIENT % BY WEIGHT Gel-Formingcomposition 25-55  Plasticizer 5-40 Water 15-40  Other Ingredients,e.g., color, flavor, or 0.1-10   sweetener.

As with the matrix formulation, the gel-forming polymer may be agelatin. The gelatin may exhibit a Bloom in the range of about 80 toabout 250. The plasticizer of this sheath formulation may be a polyol,such as, for example, a polyol selected from glycerol, sorbitol,maltitol, xylitol, or combinations thereof.

In another embodiment, the matrix formulation includes the followingingredients in the specified ranges, after drying:

TABLE 3 Matrix Formulations INGREDIENT % BY WEIGHT Gel-Formingcomposition 30-70 Polymer modifier 0.25-5   Plasticizer 10-30 Water 5-15 Active Ingredient  1-25 Other Ingredients 0.1-5  

Again, the matrix formulation may include a gelatin as the gel-formingpolymer. In this instance, the gelatin may exhibit a Bloom in the rangeof about 0 to about 80. Likewise, the plasticizer may be a polyol, suchas one selected from the list set forth above. Also, the polymermodifier again may be a carboxylic acid, such as one selected from thelist above.

In this embodiment, the capsule formulation also may include a sheaththat includes the following ingredients in the specified ranges:

TABLE 4 Sheath Formulations, After Drying INGREDIENT % BY WEIGHTGel-Forming composition 10-70 Plasticizer 10-30 Water  5-15 OtherIngredients 0.1-10 

The gel-forming polymer of this sheath formulation may be a gelatin,which exhibits a Bloom in the range of about 100 to about 175.

It will be understood that different percentages may be selected withinthe above ranges so that the sum of the percentages of the sheathingredients is equal to 100%. If additional ingredients are used, thepercentages will be adjusted within the ranges listed to accommodate theadditional ingredients.

In the case of a capsule formulation including both a matrix and asheath, the matrix may include a first gel-forming polymer and a firstplasticizer and the sheath may include a second gel-forming polymer anda second plasticizer. Depending upon the specific formulation, the firstand second gel-forming polymers may be either identical to each other ordiffer in their chemical compositions, Bloom values and/or amounts.Likewise, the first and second plasticizers may be identical or differin their compositions and/or amounts.

The chewable soft capsule formed from the above mixture, after beingdried for storage and subsequent use, is comprised of the followingingredients in the specified parts by weight:

TABLE 5 Capsule Composition, After Drying INGREDIENT % BY WEIGHT FirstGel-Forming Polymer 20-80 Second Gel-Forming Polymer  5-25 FirstPlasticizer 10-40 Second Plasticizer  1-10 Polymer Modifier 0.5-10 Active Ingredient 0.01-70   Other Ingredients 0.1-15  Water  5-20

EXAMPLES Examples 1-5

The following examples describe the manufacture and testing of variousmatrix formulations for acceptable practice.

Gelatin, gelatin hydrolysate, and glycerol were mixed and heated toabout 65° C. overnight. Citric acid was then added and masses weremolded and dried at 20° C. under low humidity (20-30%) until the totalwater content reached about 10%. Dried samples were tested for hardness,water content, and other texture analysis. The hardness ranged fromabout 1 to about 100 gram force, using a texture analyzer fitted with around ball probe. The following example formulations are provided forpurposes of illustration of certain aspects of the present invention andare not intended to limit the scope thereof. The optimum percentages ofeach ingredient will depend upon the overall formulation contents, andthe identity of the individual ingredients. However, evaluation andselection of the most desirable formulation will be well within theskill of practitioners in this area, once they are familiar with thepresent disclosure.

The values provided in Table 6 for each compound represent the parts perweight of that compound, and the corresponding hardness obtained:

TABLE 6 Matrix Compositions for Examples 1-5 COMPONENT 1 2 3 4 5 Gelatin5.9 10 10 10 0 Complete Gelatin 5.9 10 10 10 10 Hydrolysate Sorbitol14.1 10 20 0 10 Glycerol 5.9 0 10 10 10 Water Citric Acid 1.4 1.0 1.01.0 1.0 Hardness(g) by 4 103 7 59 1 Texture AnalyzerHardness was measured after drying. The above amounts are in weightratios. Water was adjusted so that the water % is constant and around28% of the mass before drying. A complete gel hydrolysate is ahydrolyzed gelatin that has zero Bloom (as used herein, the term“hydrolysate” may indicate a partial or complete hydrolysate, asindicated in the context where the term is used).

Example 6 A Soft Chewable Capsule Composition

A soft chewable capsule composition according to the invention caninclude the following matrix and sheath:

TABLE 7 Capsule Compositions MATRIX COMPOSITION SHEATH COMPOSITIONGlycerol 27.1 Glycerol 16.96 gelatin (60-80 Bloom) 9.03 Sorbitol 16.96sorbitol 9.03 gelatin (100 Bloom) 39.92 gel hydrolysate 27.1 citric acid1 citric acid 1.79 water 24.95 sucralose 0.15 flavor 0.2 water (prior todrying) 25.58 color 0.004 flavor 0.2 color 0.004

Example 7 Effect of the Polymer Modifier on Matrix Properties

A gel matrix consisting 14.6% gelatin (60-80 Bloom), 14.6% glycerin,14.6% Sorbitol Special™ (SPI Polyols, Inc., New Castle, Del.), 40% water(before drying) and 1.48% citric acid was made by subjecting the mixtureto heat at 60° C. for about 2 hours. The cooked matrix had a meltingpoint of 29° C. After 24 hours of incubation, the same matrix had amelting point of 25.3° C. and its viscosity was reduced to 52% of theinitial value, as measured by a cone and plate rheometer (TAinstruments, Leatherhead, England).

Example 8 Matrix and Sheath Composition and Method of Manufacturing

A matrix composition consisting of:

Gelatin (60-80 Bloom) 9.68 Gelatin hydrolysate 29.05 Citric acid 1.80Sucralose 0.15 Glycerin 21.28 Water 25.12 Color and flavor, add to100.00

Gelatin and gel hydrolysate were dissolved in water in presence of theplasticizer at about 60° C. The polymer modifier was also added to themass and was allowed to modify the mass structure by incubation at 60°C. for 12 hours. The above matrix formula had water activity of 0.39.After incubation, encapsulation was performed using a rotary diemachine, with the following gel sheath composition:

Gelatin (100 Bloom) 39.92 Citric acid 1.00 Sorbitol Special ™ 19.57Glycerin 19.57 Water 24.95 Color 0.004

Capsules were dried in a tumble drier where cold air was initially usedto congeal the capsule mass and keep the shell shape integrated. Dryingwas then completed using a tunnel dryer. Dried capsules had a 9.8% watercontent, and firm texture (a hardness peak of 91.9 gram force) asmeasured using a TA-XT2 texture analyzer (Texture Technologies,Scarsdale, N.Y.) using a standard two bite texture profile analysis witha 0.25 inch diameter probe at room temperature.

Example 9 Matrix and Sheath Composition and Method of Manufacturing

The matrix composition consisted of:

Gelatin (60-80 Bloom) 9.03 Gelatin hydrolysate 27.09 Citric acid 1.79Sucralose 0.14 Glycerin 36.18 Water 25.56 Color and flavor, added to100.00

Gelatin and gel hydrolysate were dissolved in water in presence of theplasticizer at about 60° C. The polymer modifier was also added to themass and was allowed to modify the mass structure by incubation at 60°C. for 12 hours. After incubation, encapsulation was performed using arotary die machine, with the following gel sheath composition:

Gelatin (100 Bloom) 39.92 Citric acid 1.00 Sorbitol Special ™ 19.57Glycerin 19.57 Water 24.95 Color 0.004

Capsules were dried in a tumble drier where cold air was initially usedto congeal the capsule mass and keep the shell shape integrated. Dryingwas then completed using a tunnel dryer. Dried capsules had a 10% watercontent, and softer texture (a hardness peak of 22.7 gram force) asmeasured using a TA-XT2 texture analyzer using a standard two bitetexture profile analysis with a 0.25 inch diameter probe at roomtemperature.

Example 10 Chewable Soft Capsule Matrix Containing Active Ingredient inSolution

A chewable soft capsule formulation contains 6.25 mg per unit dose ofthe antihistaminic, diphenhydramine, was manufactured using the methodsexplained in examples 9 and 10 where the active was incorporated to thefill matrix after the incubation with the polymer modifier.

The matrix consisted of 9% gelatin (60-80 Bloom), 26.9% gelatinhydrolysate 26.9% glycerin, 9% Sorbitol Special™, 1.8% citric acid,24.7% water, and less 1% of sweetener, color, and flavor.

Example 11 Chewable Soft Capsule Matrix Containing Active Ingredient asa Suspension

A chewable soft capsule matrix containing 80 mg per dose of theanalgesic antipyretic active, Paracetamol was manufactured using themethods explained in examples 9 and 10 where the active was incorporatedto the fill matrix after the incubation with the polymer modifier.

The matrix consisted of 8.1% gelatin (60-80 Bloom), 24.4% gelatinhydrolysate 31.8% glycerin, 1.6% citric acid, and 10.8% Paracetamol ascoated powder.

Certain modifications and improvements will occur to those skilled inthe art upon a reading of the foregoing description. It should beunderstood that all such modifications and improvements are properlywithin the scope of the following claims.

What is claimed is:
 1. A chewable soft capsule comprising a sheathencapsulating a flowable matrix: the sheath comprising: a firstgel-forming composition comprising gelatin, partially hydrolyzedgelatin, hydrolyzed gelatin, carbohydrates, carbopolymers,polysaccharides, starch, modified starch, alginates, hydroxypropylmethylcellulose, methyl cellulose, or a combination thereof; a firstplasticizer; a first polymer modifier; water; and the flowable matrixcomprising: a second gel-forming composition comprising gelatin,partially hydrolyzed gelatin, hydrolyzed gelatin, carbohydrates,carbopolymers, polysaccharides, starch, modified starch, alginates,hydroxypropylmethyl cellulose, methyl cellulose, or a combinationthereof; a second plasticizer; a second polymer modifier; at least oneactive pharmaceutical ingredient; and water; wherein the first andsecond polymer modifiers comprise at least one of lactic acid, fumaricacid, tartaric acid, citric acid, glycolic acid, salts thereof, orcombinations thereof.
 2. The chewable soft capsule of claim 1, whereinthe sheath further comprises at least one of a flavoring agent, acoloring agent, a sweetener, and a taste masking agent.
 3. The chewablesoft capsule of claim 1, wherein the flowable matrix further comprisesat least one of a flavoring agent, a coloring agent, a sweetener and ataste masking agent.
 4. The chewable soft capsule of claim 1, whereinthe first gel-forming composition comprises gelatin.
 5. The chewablesoft capsule of claim 1, wherein the first gel-forming compositioncomprises about 25% to about 55% of the sheath by weight prior todrying; and about 10% to about 70% of the sheath by weight after drying.6. The chewable soft capsule of claim 1, wherein the first gel-formingcomposition exhibits a Bloom of about 80 to
 250. 7. The chewable softcapsule of claim 1, wherein the first gel-forming composition exhibits aBloom of about 100 to
 175. 8. The chewable soft capsule of claim 1,wherein the second gel-forming composition comprises gelatin andhydrolyzed gelatin.
 9. The chewable soft capsule of claim 1, wherein thesecond gel-forming composition comprises about 15% to about 80% of theflowable matrix by weight prior to drying and about 30% to about 70% ofthe flowable matrix by weight after drying.
 10. The chewable softcapsule of claim 1, wherein the second gel-forming composition exhibitsa Bloom of about 0 to about
 250. 11. The chewable soft capsule of claim1, wherein the second gel-forming composition exhibits a Bloom of about0 to about
 80. 12. The chewable soft capsule of claim 1, wherein thewherein the first and second polymer modifiers comprise citric acid. 13.The chewable soft capsule of claim 1, wherein the polymer modifiercomprises about 0.1-10% of the sheath by weight; and about 0.1-10% ofthe matrix by weight.
 14. The chewable soft capsule of claim 1, whereinthe first and second plasticizers comprise at least one of glycerol,sorbitol, maltitol, xylitol, or combinations thereof.
 15. The chewablesoft capsule of claim 1, wherein the first plasticizer comprises about5% to about 40% of the sheath by weight prior to drying and about 10% toabout 30% of the flowable matrix by weight after drying.
 16. Thechewable soft capsule of claim 1, wherein the second plasticizercomprises about 5% to about 40% of the flowable matrix by weight priorto drying; and about 10% to about 30% of the flowable matrix by weightafter drying.
 17. The chewable soft capsule of claim 1, wherein theflowable matrix comprises about 5% to about 30% water by weight prior todrying; and about 5% to about 15% water by weight after drying.
 18. Thechewable soft capsule of claim 1, wherein the sheath comprises about 15%to about 40% water by weight prior to drying; and about 5% to about 20%water by weight after drying.
 19. The chewable soft capsule of claim 1,wherein the flowable matrix has a hardness of about 1 gram to about 103grams.
 20. The chewable soft capsule of claim 19, wherein the activeingredient comprises at least one of NSAIDs, analgesics,antihistaminics, anti-asthmatics, anti-epileptics, antibiotics,decongestants, anti-allergenics, vitamins, mineral supplements, foodsupplements, fruit extracts, or herbals further comprisingdiphenhydramine, amoxycillin, aspirin, azythromycin, celecoxib,clarythromycin, ibuprofen, meloxicam, naproxen, paracetamol, phenytoin,salbutamol, theophylline, vitamin A, vitamin B complex, vitamin D,vitamin E, vitamin K, vitamins C, or a combination thereof.